FDA Drafts Guidance for Change Control Plans in AI/ML-Enabled Device Software Functions in the US

The US Food and Drug Administration (FDA) has released a draft guidance on predetermined change control plans for artificial intelligence (AI)/machine learning (ML)-enabled device software functions (ML-DSFs). The aim is to support the development of safe and effective medical devices that implement machine learning, which allows devices to learn and perform tasks on their own. The new plan is part of the FDA’s least burdensome approach for regulating AI/ML-enabled device software functions designed to increase innovation. Manufacturers seeking to change their already-approved software functions for safety or effectiveness purposes will no longer be required to submit new marketing submissions if the FDA approves the predetermined changes listed in the submitted PCCP. The FDA said manufacturers must engage early regarding their proposed PCCP for ML-DSFs through the Q-submission process and transparency with patients is paramount.